Conformity Assessment Approaches and Best Practices NIST Public Workshop. Session 4: Conformity Assessment Case Study Personal Protective Technologies

Conformity Assessment Approaches and Best Practices NIST Public Workshop Session 4: Conformity Assessment Case Study Personal Protective Technologies Maryann D Alessandro, Ph.D. Director, National Personal Protective Technology Laboratory bpj5@cdc.gov April 12, 2012 1

Presentation Overview NIOSH s PPT Program and Its Background in Conformity Assessment IOM CA Report Recommendations NIOSH Strategy to Address Recommendations Status of Implementing the Strategy 2

NIOSH PPT Program Mission An estimated 20 million workers use personal protective equipment on a regular basis to protect themselves from job hazards. The MISSION of the PPT program is to prevent workrelated injury, illness and death by advancing the state of knowledge and application of personal protective technologies (PPT). 3

NIOSH Respirator Conformity Assessment Activities Respirator Approval Activities Engineering Evaluation Respirator Testing QA Plan Evaluation Post Approval Activities Manufacturing Site Audits Respirator Product Audits Respirator Evaluations 4

NIOSH Conformity Assessment Foundational Background June 2008 May 2010 February 2011 May 2011 October 2011 NA PPT Program Evaluation Report: Five Recommendations PPT Program s Action Plan to Implement Recommendations IOM s Analysis of NA Report Recommendation 1: Comprehensive CA Program NIOSH Docket # 237 Public Comment on IOM CA Report NIOSH PPT Conformity Assessment Working Group Established 5

NA Report Observations NIOSH certification of respirators has had a significant positive impact on the quality of respirators available in the workplace. There is no analogous federal process for ensuring the certification of the efficacy of nonrespiratory PPT. NA Report Recommendation 1 Oversee all PPT certification in order to ensure a minimum uniform standard of protection and wearability. The National Program should collaborate with other relevant government agencies, private-sector organizations, and not-for-profit organizations to conduct an assessment of the certification mechanisms needed to ensure the efficacy of all types of PPT (emphasis added); and 6 6

Engaging the IOM to Assess Nonrespiratory PPT Certification 8

Charge to the IOM Committee Assess the [conformity assessment] mechanisms needed to ensure the efficacy of nonrespiratory personal protective technologies (PPT) Examine various approaches to various [conformity assessment elements] (e.g., federal laboratory certification, third-party certification, federal certification of nongovernmental laboratories) Provide recommendations on [conformity assessment for] non-respiratory PPT 9

IOM Report Recommendations Recommendation 1 - Develop and Implement Risk-Based [Conformity Assessment Processes] for Nonrespiratory PPT Recommendation 2 - Enhance Research, Standards Development, and Communication Recommendation 3 - Establish a PPT and Occupational Safety and Health Surveillance System 11

IOM Report Conformity Assessment Tiered Approach Low risk Manufacturer attestation to the standard Medium risk Third-party testing and certification by accredited entities High risk Third-party testing and certification by accredited entities Government involvement to provide oversight and to assist in enforcement 12

NIOSH Conformity Assessment Foundational Background Responses to NIOSH Docket # 237 3M Corporation International Safety Equipment Association (ISEA) International Association of Firefighters (IAFF) Kimberly-Clark Corporation International Personal Protection, Inc. (Stull & Stull) Oil and Gas Industry Representative (Reznicek) 14

The Status of Conformity Assessment of PPE in the US Few formal requirements exist in the US that PPT be independently tested and certified Respirators require NIOSH testing and approval Third-party certification is required in fire and emergency service standards from NFPA Other workplace PPE such as safety glasses, hard hats and fall protection may be tested by manufacturer to show conformance to a consensus standard 16

The Status of Conformity Assessment of PPT in the US Manufacturers develop products to meet consensus standards Checks and balances in place through litigation Current legal processes do not penalize for false claims ISEA Draft Conformity Assessment Standard under development Consensus standard organizations sometimes incorporate CA in support of performance standards 17

Guiding Principles for the NIOSH Strategy First: Collaborate. The National Program should collaborate with other relevant government agencies, private-sector organizations, and not-for-profit organizations to conduct [the] assessment (NA Report) Second: Do no harm. The committee recognizes that many conformity assessment processes already in place can fit this framework. (IOM Report) Third, Don t re-invent the wheel. A single reputable source of information on all certified PPT is needed...[that] could link to lists of certified equipment from accredited third-party organizations. (IOM Report) 18

PCAWG Members and Consultants International Personal Protection, Inc. JSJ and Associates 19

What is our Challenge? Develop consensus regarding what types of assurance are needed to demonstrate that particular PPE products meet standards to which they are marked. What is the basis for establishing a national framework to address the conformity assessment of nonrespiratory PPE? What are the appropriate implementation mechanisms and needed authorities? What level of conformity assessment is necessary under various circumstances? What will the PPE manufacturer and user communities be realistically willing and able to support? 20

Working Group Schedule 21

Working Group Approach Develop a framework for a national strategy for nonrespiratory PPT conformity assessment 22

Terminology: Key Activities TERMINOLOGY (SUB-GROUP) Identify applicable terms needed to establish consistent language Definitions List of important terms List of terms which may be referenced Terms selected for deletion 23

Terminology: Important Terms Accreditation Accreditation body Approval Attestation Certificates or marks of conformity Certification Conformance Conformity assessment Conformity assessment body Declaration Environmental conditions Failure First party Hazard Hazard identification Incorrect use Inspection Non-conformance Probability Regulations Revocation Risk Risk assessment Risk Evaluation Risk Management Risk Reduction Second Party Severity Supplier s Declaration Surveillance Third Party Type Test Unilateral Arrangement TERMINOLOGY (SUB-GROUP) Do these terms capture those needed for the WG products? 24

Products and Standards: Key Activities PRODUCTS AND STANDARDS (SUB-GROUP) Inventory product and performance standards Identify classes of PPE to which specific standards and requirements apply Assess national and international conformity assessment processes Identify existing third party certifiers of PPE, their current accreditation, and standards to which they test products Document and identify PPE integration and interface issues Outputs will feed into the development of the conformity assessment model(s). 25

Surveillance Data: Key Activities SURVEILLANCE DATA (SUB-GROUP) Over 30 data sources assessed and documented to define data gathering needs Case studies and sources of incidents evaluated Need for improved approaches identified Assessing PPE failures and inadequacies Reporting incidents of PPE failure Are there any other databases or sources of information which may provide information on PPE conformity? Reporting fraudulent or counterfeit PPE in the marketplace 26

Medwatch Adverse Event and Reporting System SURVEILLANCE DATA (SUB-GROUP) Voluntary Media Electronic Paper (mail or fax) Phone 40,000 incidents/year Resources 1.5 personnel $300K/year dedicated to data entry 27

Compliance and Enforcement: Key Activities COMPLIANCE AND ENFORCEMENT (SUB-GROUP) Assess and document existing national compliance programs Enumerate needs, gaps, and deficiencies in these programs Conformity assessment requirements Enforcement authority guidelines for classes of PPE Benchmark international conformity assessment programs 28

- Asia o Japan - Australia - Europe o England o Germany o Sweden - North America o Canada - Ontario o Canada Quebec o Mexico - South America o Brazil Candidate Countries to Benchmark COMPLIANCE AND ENFORCEMENT (SUB-GROUP) Are these the right countries? Which other countries should be considered? 29

Benchmarking Approach: Survey COMPLIANCE AND ENFORCEMENT (SUB-GROUP) Key Issues Are CA standards voluntary or required by law, regulation, or other authority? What quantitative surveillance data were used in structuring the PPE CA system? How were the categories of risk determined? What are the major issues concerning compliance and enforcement? What successes/benefits have you realized from the program? 30

Levels of Risk: Key Activities LEVELS OF RISK (SUB-GROUP) Develop appropriate levels of risk model Define appropriate use of existing data in the absence of complete surveillance data Explore and develop operations research methodologies (expert decision models) to assign risk levels Develop a risk assessment process 31

Working Group Schedule 32

Quality Partnerships Enhance Worker Safety & Health Disclaimer: Visit Us at: http://www.cdc.gov/niosh/npptl/ The findings and conclusions in this presentation have not been formally disseminated by the National Institute for Occupational Safety and Health and should not be construed to represent any agency determination or policy. Thank you! 33